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Serving leading biopharmaceutical companies globally:

Baxter
US Army
Colorcon
Medtronic
Teva
Cipla
Chinese Patent Office
Mallinckrodt
Accenture
Healthtrust

Generated: October 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075417

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NDA 075417 describes CLOZAPINE, which is a drug marketed by Mayne Pharma, Barr Labs Inc, Ivax Sub Teva Pharms, Sun Pharm Inds Inc, Mylan, Mylan Pharms Inc, Aurobindo Pharma Ltd, Teva Pharms Usa, Sandoz, Par Pharm, and Accord Hlthcare, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the CLOZAPINE profile page.

The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for NDA: 075417

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 075417

Suppliers and Packaging for NDA: 075417

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE
clozapine
TABLET;ORAL 075417 ANDA Mylan Pharmaceuticals Inc. 0378-0825 0378-0825-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0825-01)
CLOZAPINE
clozapine
TABLET;ORAL 075417 ANDA Mylan Pharmaceuticals Inc. 0378-0860 0378-0860-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0860-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 27, 1999TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 27, 1999TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Apr 15, 2010TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

McKinsey
Daiichi Sankyo
Julphar
US Department of Justice
Harvard Business School
Teva
Boehringer Ingelheim
Mallinckrodt
Moodys
Farmers Insurance

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